What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?

February 2013

This issue of Policy Forum (Volume 3, Number 3, February 13, 2013) — "What Does the Second Circuit’s Recent Decision in United States v. Caronia Not Say?" — deconstructs the landmark decision in United States v. Caronia of when promotional activities by pharmaceutical manufacturers are protected as free speech and provides advice to the government for the prosecution of these cases in the future. Author Geoffrey R. Kaiser, former federal prosecutor of Defendant Alfred Caronia and current owner of Kaiser Law Firm, PLLC, explains that Caronia has not appreciably changed the government’s ability to prosecute misbranding offenses, but that the government may choose to not prosecute similar cases in the future. Kaiser recommends that Courts allow the use of promotional speech as evidence that a drug or device has been marketed for an intended use inconsistent with its approved labeling. He also recommends that prosecutors ensure that their presentation of the evidence and their arguments to the jury are closely tied to the underlying behavior actually criminalized by the Food, Drug and Cosmetic Act.